Clinical Notes: GI Bug Sickens German Kids

Thousands of German schoolchildren fell ill last week, all of whom ate school lunches provided by the same catering company. Also this week: an anti-IL-17 drug shows promise in psoriasis.

German Schoolkids Sickened by Lunches

Nearly 7,000 schoolchildren in eastern Germany had fallen ill with gastrointestinal symptoms as of Friday, tied to lunches served at their schools, the German publication Der Spiegel reported on its website.

Diarrhea and vomiting were the principal symptoms in the outbreak, which began earlier this week. The afflicted children had all eaten lunches served at schools supplied by a single catering company, Sodexo.

Officials of the firm, which also does business in the U.S., said they did not believe Sodexo's food was responsible. Der Spiegel quoted a spokesman as saying "less than 5% of the schools we supply have been affected."

The Robert Koch Institute in Berlin was seeking to identify the causative agent, with noroviruses, Salmonella, or chemical toxins the leading suspects. It had not reached a conclusion as of late Friday, German media reported.

Secukinumab Advances for Psoriasis

The anti-IL-17 antibody drug secukinumab (AIN457) appeared significantly effective against moderate to severe psoriasis affecting the hands and feet in a phase II study, its manufacturer said.

New analyses from a previously reported 404-patient randomized trial showed that symptoms in the hands and feet were substantially reduced in 54% of patients receiving secukinumab after 1 month, compared with 19% of placebo-treated patients (P=0.005), Novartis said in a statement.

Symptoms in the nails were also relieved significantly more with the drug than with placebo, the company indicated.

The findings were reported at the European Academy of Dermatology and Venereology in Prague last week.

The FDA approved a more flexible dosing schedule for the long-acting injectable schizophrenia drug paliperidone palmitate (Invega Sustenna), according to its manufacturer, Janssen Pharmaceuticals.

Formerly, the product's label called for treatment to begin with two initiation doses 1 week apart, with maintenance dosing monthly thereafter. In particular, the second initiation dose was to be given in a window extending from 2 days before to 2 days after the 1-week time point.

That remains unchanged, but for patients who cannot receive the second initiation dose as scheduled, the label will now permit a larger window -- 4 days before to 4 days after the 1-week point.

The new dosing instructions also indicate that, if the second dose is missed altogether, the procedure for restarting treatment can vary depending on the length of time since the first injection.

Janssen also said that changes were made to the "Warnings and Precautions" section of the label, including cautions about co-administration with strong CYP3A4 inducers and use in nursing mothers and patients with Lewy body disease or Parkinson's disease.

NIH Sponsors Drug Trial for Rare Muscle Disease

A drug therapy for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM), will be tested in a trial sponsored by the National Institutes of Health, the agency said.

Called DEX-M74 and originally discovered by NIH scientists, the drug is intended to boost sialic acid levels in muscle proteins. One of the consequences of the genetic mutation underlying HIBM is low levels of sialic acid. DEX-M74 is metabolized into sialic acid in vivo.

Preclinical studies at NIH using a mouse model of HIBM indicated that the drug would restore normal sialic acid levels in muscle. The upcoming clinical trial would be the first test of the drug in humans.

Initially, safety and tolerability of a single DEX-M74 dose will be evaluated, to be followed by a phase I/II safety study of multiple doses. If the outcome of those trials is favorable, a phase II efficacy study would follow, the NIH said.

A private company, New Zealand Pharmaceuticals, has licensed rights to DEX-M74 and will help support the initial trials.

Cuba Faces Cholera Outbreak

An outbreak of cholera in Cuba may have returned, a month after the government declared it had been stopped, the Miami Herald reported.

During the summer, the Cuban government said that 417 cholera cases, including three deaths, had been found in the eastern city of Manzanillo. On August 28, though, it said the outbreak was over.

But unofficial sources told the Herald that a total of 46 additional cases had cropped up in two other widely separated towns.

The sources said that, in the western town of Cabañas, a local clinic had been turned into an isolation facility for cholera victims, as was part of a hospital in San Luis, about 80 miles east of Manzanillo.

Cuba had been cholera-free for many decades, the Herald noted. The cases seen this year are thought to be linked to the outbreak in Haiti that began in 2010 after a destructive earthquake.

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